Buttress fixation for a circular stapler

ABSTRACT

A stapling apparatus includes a body portion, a staple cartridge disposed within the body portion, and a buttress removably attached to the staple cartridge. The staple cartridge includes a plurality of staple receiving slots defined in a tissue contacting surface of the staple cartridge, with each staple receiving slot of the plurality of staple receiving slots including a staple disposed therein. The buttress includes a plurality of tabs at an outer edge of the buttress. The buttress is releasably retained on the staple cartridge by at least one tab of the plurality of tabs extending into a staple receiving slot of the plurality of staple receiving slots defined in the staple cartridge.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/875,865, filed Oct. 6, 2015, which is a continuation of U.S. patentapplication Ser. No. 13/648,703, filed Oct. 10, 2012 (now U.S. Pat. No.9,161,753), the entire contents of each of which are incorporated hereinby reference.

TECHNICAL FIELD

The present application relates to surgical stapling apparatus and, inparticular, surgical stapling apparatus having a buttress releasablyfixed thereto.

BACKGROUND

Attaching surgical buttresses or staple line reinforcement materials tosurgical staplers is known. Trumbull et al., U.S. Pat. No. 5,263,629,the disclosure of which is hereby incorporated by reference herein inits entirety, discloses an absorbent and bioabsorbable pledget materialattached to a surgical stapler. Buttresses used in conjunction with atubular sleeve have been proposed. For example, U.S. Pat. No. 5,503,638to Cooper et al., the entire disclosure of which is hereby incorporatedby reference herein, proposes a tubular sleeve dimensioned to fit overand closely surround the jaws of a stapler. The sleeve can be made fromnon-woven polyethylene attached to a strip of material made from animaltissue.

McKean et al., U.S. Pat. No. 5,542,594, the entire disclosure of whichis hereby incorporated by reference herein, discloses a staplingapparatus having biocompatible fabric releasably attached thereto. Thefabric can be tubular in configuration for attachment to the staplingapparatus, or can be attached using pins.

Tarinelli et al., International Publication No. WO 08/109125, the entiredisclosure of which is hereby incorporated by reference herein,discloses an anchor, or a suture material, for attaching a buttress,which is released when the anchor, or suture, is cut by a knife.

Mooradian et al., WO 03/082126, the entire disclosure of which is herebyincorporated by reference herein, discloses a circular staplingapparatus having a buttress material positioned on the staple cartridgeand/or anvil. The buttress material may be preformed so as to have araised central region so that it can be positioned on the staplecartridge and/or anvil.

There is a need for reliable methods of removably attaching a stapleline reinforcement material or buttress material onto a circularstapling apparatus, or other stapling apparatus, so that the materialdoes not interfere with the operation of the apparatus, remains on theapparatus until after the staples are fired, and is convenient and easyto install and use.

SUMMARY

In an aspect of the present disclosure, a circular stapling apparatushas an anvil assembly with an anvil member and a shaft, and a tubularbody portion. The shaft of the anvil assembly is connectable to thetubular body portion so that the anvil assembly is movable toward andaway from the tubular body portion. A buttress material is removablyattached to the anvil assembly, staple cartridge, or both, by at leastone anchor, at least one of the anvil assembly and staple cartridge havea notch shaped for retaining the anchor thereto.

The apparatus has a pusher with a fingers for driving the staples. Atleast one of the fingers includes a protrusion. At least one of theanvil assembly and staple cartridge has a notch shaped for retaining theanchor, the pusher being movable to move the protrusion into engagementwith the anchor in the notch.

The anchor may be a length of suture. The apparatus may further compriseadhesive. The apparatus may further comprise a fastener holding theanchor and being positioned adjacent the notch. In certain embodiments,the notch pinches the anchor. The notch can be defined in a tissuecontacting surface of the at least one of the anvil assembly and staplecartridge. The notch may communicate with a staple receiving recess ofthe staple cartridge. The notch may communicate with a staple formingrecess of the anvil member.

In certain embodiments, the notch has a first portion and a secondportion, the first portion being smaller in dimension than the diameterof the anchor, and the second portion being bigger than the firstportion.

The buttress material can define features selected from the groupconsisting of slits and perforations. The buttress material can defineslits that extend from an outer edge thereof. The protrusion may cut theanchor.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed surgical device are disclosedherein, with reference to the following drawings:

FIG. 1A is a perspective view of a stapling instrument in accordancewith an embodiment of the present disclosure;

FIG. 1B is a partial cross-sectional view of the stapling instrumentshown in FIG. 1A;

FIG. 2A is a top plan view of a staple cartridge, and a detailed view ofa portion thereof, in accordance with an embodiment of the presentdisclosure;

FIG. 2B is a cross-sectional view of the staple cartridge of FIG. 2A,taken along line 2B-2B of FIG. 2A;

FIG. 3 is a top plan view of a surgical buttress in accordance with anembodiment of the present disclosure;

FIG. 4 is a top plan view of a staple cartridge, and a detailed view ofa portion thereof, in accordance with an embodiment of the presentdisclosure;

FIG. 5 is a perspective view of a pusher member in accordance with anembodiment of the present disclosure; and

FIG. 6 is a top plan view of a buttress with an outer edge in accordancewith another embodiment of the present disclosure.

DETAILED DESCRIPTION

Persons having skill in the art will understand the present inventionfrom reading the following description in conjunction with theaccompanying drawings. Reference characters indicate the same or similarelements throughout the drawings. As is customary, the term “distal”refers to a location farther from the user of the instrument and theterm “proximal” refers to a location that is closer to the user of theinstrument.

A circular stapling instrument or apparatus (also referred to herein asa stapler) 10 is shown in FIGS. 1A-1B and has a handle portion 12, atubular body portion 14, and an anvil assembly 20. The anvil assembly 20is at the distal end of the instrument 10, and is movable toward andaway from the tubular body portion 14. The handle portion 12 has atleast one movable handle 33 for actuating the firing of staples 50 andthe cutting of tissue 1, 2. A knob 35 is at the proximal end of thehandle portion 12 and can be turned to move the anvil assembly 20 towardthe tubular body portion 14 or away from the tubular body portion 14. Abuttress 74 is shown generally disposed around the shaft 23.

Although a circular stapling apparatus is described in detail herein, inany of the embodiments disclosed herein, the stapling apparatus may be alinear endoscopic stapler, a linear stapler for open surgery, atransverse surgical stapler, or other surgical device. Circular staplersare disclosed in U.S. Pat. No. 5,915,616, the disclosure of which ishereby incorporated by reference in its entirety. Endoscopic staplersare disclosed in U.S. Pat. Nos. 6,330,965 and 6,241,139, the disclosuresof which are hereby incorporated by reference in their entirety.Transverse surgical staplers are disclosed in U.S. Pat. No. 5,964,394,the disclosure of which is hereby incorporated by reference in itsentirety. U.S. Pat. No. 7,334,717, the disclosure of which is herebyincorporated by reference in its entirety, discloses a stapler intendedfor open surgical procedures.

The tubular body portion 14 can be flexible, straight or curved, orotherwise configured for the surgical procedure. The distal end of thetubular body portion 14 has a staple cartridge 32 disposed therein. Thestaple cartridge 32 has a circular array of staple retaining orreceiving slots 52 defined in a tissue contacting surface 51 of thestaple cartridge 32. The anvil assembly 20 has an anvil member 21 with acircular array of staple forming recesses that correspond to the stapleretaining or receiving slots 52. The anvil assembly 20 also has a shaft23 that connects with a rod 15 in the tubular body portion 14.

A staple pusher 64 is disposed in the staple cartridge 32 and has aplurality of fingers or pushers 65 that are aligned with the staplereceiving slots 52. The staple pusher 64 is a conical member that isdisposed in the staple cartridge 32. The staple pusher 64 is movable inthe distal direction to drive the staples 50 out of the staple cartridge32 and toward the staple forming recesses in the anvil member 21. Thereare three circular rows of staples that are driven into tissue, as shownin FIG. 2. A knife 30 has a cylindrical shape and is disposed radiallyinwardly of the pushers 65. The knife 30 is mounted to a surface of thestaple pusher 64 so that after the staples 50 are driven through tissue1, 2 and into the staple forming recesses, the tissue radially interiorto the circular rows of staples is cut. The staple cartridge 32 can be aremovable and replaceable assembly so that the rest of the circularstapling apparatus 10 can be re-sterilized and reused, or the circularstapling apparatus 10 can be reused on the same patient withoutre-sterilization.

The rod 15 inside the tubular body portion 14 extends proximally throughthe apparatus 10 to the knob 35. The distal end of the knob 35 isattached to a member that has a helical groove defined on a surfacethereof. A pin attached to a proximal end of the rod 15 is disposed inthe groove so that, as the knob 35 is rotated, the pin travels in thegroove, moving the rod 15 in a distal or proximal direction. The anvilshaft 23, which is attached to the rod 15, is also moved, moving theanvil assembly 20 toward or away from the tubular body portion 14. Whenthe knob 35 is rotated in a first direction, the anvil assembly 20 ismoved away from the tubular body portion 14, allowing tissue to beplaced between the anvil assembly 20 and the tissue contacting surface51 of the staple cartridge 32. When the knob 35 is rotated in a seconddirection, the anvil assembly 20 is moved toward the tubular bodyportion 14, allowing the tissue to be clamped between the staplecartridge 32 and anvil assembly 20. Other means of moving the anvilassembly with respect to the tubular body portion are contemplated. Itis also contemplated, in any of the embodiments disclosed herein, thatthe instrument 10 can be connected to a motorized assembly. For example,a motorized assembly can be provided in the handle portion 12, and powercan be supplied from external sources, or from a battery provided in thehandle portion 12.

The pivotable handle or handles 33 can be connected to a tubular memberor pair of bands that are attached to the staple pusher 64 by, forexample, linkages or the like. In this way, when the handle or handles33 are depressed, the tubular member or bands are advanced, advancingthe staple pusher 64, driving the staples 50 through tissue 1, 2 andagainst the anvil member 21, and advancing the knife 30 to cut tissueradially inward of the rows of surgical staples 50.

As shown in FIGS. 2A and 2B, a buttress fixation system 70 is providedon the staple cartridge 32. The staple cartridge 32 has a plurality ofstaple receiving slots 52 defined in a tissue contacting surface 51therein. Only a portion of the staple receiving slots 52 are shown inFIG. 2A, but it is understood that the rows of staple receiving slots 52extend all the way around the circular face of the staple cartridge 32.The staple receiving slots 52 have an inner row 53, middle row 54, andan outer row 55. The middle row 54 of staple receiving slots 52 includesat least one notch 56 extending outwardly away from the rod 15 of theapparatus. This at least one notch 56 receives an anchor 72, which is astrap, cable, wire, thread, strand, or the like, which can be forexample, a length of suture 72. The notch 56 is configured to have ashape that pinches the length of suture 72. For example, the notch 56will have a first portion 56 a with a first dimension, and a secondportion 56 b with a second dimension. The first dimension is smallerthan the diameter, or cross-sectional dimension, of the length of suture72, so that the length of suture 72 is retained in the notch 56. Thesecond dimension is bigger than the first dimension, allowing the lengthof suture 72 to move out of the notch 56. In any of the embodimentsdisclosed herein, the notch 56 can have a shape like the number 8, theshape of the letter V, or any shape for retaining and releasing theanchor, or suture.

The anchor 72, which can be a strap, cable, wire, thread, strand,suture, or the like, is desirably a bioabsorbable suture, which can bemade from polyglycolic acid, glycolide trimethylene carbonate,polylactic acid, or any of the bioabsorbable materials from whichsutures, buttress materials, and other medical implants, can be made.Animal derived materials, which are known in the art, are alsocontemplated for the buttress and/or anchor. In any of the embodimentsdisclosed herein, the suture can be a material that is notbioabsorbable. In certain embodiments, the anchor 72 is attached to thestapler 10 and removed with the stapler 10 after the staples 50 havebeen fired. In certain embodiments, the anchor 72 is bioabsorbable andis attached to the buttress 74, or is formed as part of the buttress 74,and is left in the body of the patient. Alternatively, the surgeon cantrim the anchor or anchors 72 during surgery.

The length of suture 72 can be attached to the buttress 74 by welding,or using an adhesive, or by heat pressing, or any known method.Alternatively, the length of suture 72 can be integrally formed with thebuttress 74, as an extension thereof. For example, the buttress 74 canbe formed as a circular disc, as shown in FIG. 3, and can have strapsthat extend from the outer edge 76 thereof. The straps can separate fromthe buttress 74 at perforations, or by virtue of the bioabsorbability ofthe material. For example, the straps can be made much thinner than thebuttress 74. In another example, the straps or length of suture 72 canbe trimmed by the surgeon after the staples 50 are fired and thestapling instrument 10 is removed from the site. The anchor 72 oranchors 72 can be one or more lengths of suture material. That is, theanchor 72 can be a single piece of suture, portions of which extendinginto the notch or notches 56 to retain the buttress 74. In any of theembodiments disclosed herein, the anchor 72 comprises a plurality orpieces of suture material that extend into corresponding notches 56.

In any of the embodiments disclosed herein, a fastener can be attachedto the anchor 72, the surgical instrument 10 or both, to help retain theanchor 72 and the buttress 74 on the instrument 10. For example, thefastener can be an aglet or crush ring or clip attached to the anchor 72at a location adjacent the notch 56.

The buttress fixation system 70 allows the buttress 74 to be releasedfrom the stapler 10 so that the stapler 10 can be removed from the site.The staple pusher 64 has a plurality of pushers or fingers 65, each ofwhich extend into the staple receiving slots 52 to eject the staples 50.The fingers 65 have a shape that corresponds to the shape of the staplereceiving slot 52. The fingers 65 that are disposed in the staplereceiving slot or slots 52 that has the notch 56 have a correspondingprotrusion or extension 67 that is disposed in the notch 56. As thestaple pusher 64 is advanced, the fingers 65 advance, and the finger orfingers 65 that has the extension 67 will push the length of suture 72,strap, or the like, from the notch 56.

In any of the embodiments disclosed herein, the buttress itself can bemade from a variety of biologically compatible materials, and can bemade of the same material as the anchor. In certain preferredembodiments, the buttress material is a bio-absorbable material such aspolyglycolic acid, glycolide trimethylene carbonate copolymer,polylactic acid, glycolide dioxanone and trimethylene carbonatecopolymer, blends and copolymers or any of the bio-absorbable materialsused to make sutures, buttresses, and other medical implants.Non-absorbable materials can be used such as polypropylene or polyester.The buttress can be made from animal derived materials, which are knownin the art. For example, the buttress material can be made from porcineor bovine tissue, such as porcine dermal collagen, collagen from bovinepericardium, or other materials. The buttress can be made by extrusion,felting, knitting or braiding, molding, non-woven techniques such asmelt blown or spun bonding methods, or other methods. The buttress canbe porous or non-porous. The buttress can be a foam or mesh. Thebuttress can have layers of different materials or be some other form ofcomposite material. The buttress material can be made as described inU.S. patent application Ser. No. 13/293,215, filed on Nov. 10, 2011, nowU.S. Patent Publication No. 2013-0123816, the entire disclosure of whichis hereby incorporated by reference herein.

In any of the embodiments disclosed herein, the buttress 74 has a shapethat discourages buckling or wrinkling of the buttress 74. For example,the buttress 74 shown in FIG. 3 has slits 75 extending from the outeredge 76 thereof. Other slits or openings in the buttress 74 may beprovided. The buttress 74 has a hole in its middle for allowing theshaft of the stapler 10 to pass through.

In a further embodiment shown in FIG. 4, the circular staplinginstrument 10 has two rows of staple receiving slots 152. The staplecartridge 132 has a tissue contacting surface 151 that defines an innerrow 153 and an outer row 155 of staple receiving slots 152. Althoughonly seven staple receiving slots 152 are shown in FIG. 4, it isunderstood that the slots 152 extend all the way around the tissuecontacting surface 151 of the stapler 10. At least one of the staplereceiving slots 152 in the inner row 153 has a notch 156 for the receiptof an anchor, length of suture, strap, wire etc 72, as described abovein connection with FIGS. 2A and 3. The notch 156 has a first portion 156a and second portion 156 b, as described above in connection with FIG.2A. This buttress fixation system 170 allows the buttress 74 to bereleased from the stapler 10 so that the stapler 10 can be removed fromthe site. The stapler 10 is otherwise arranged as discussed above inconnection with FIGS. 1 through 3. The staple pusher, such as staplepusher 64, is a conical member that is advanceable to eject the staples50 from the slots 152, and has a plurality of pushers or fingers 65,each of which extend into the staple receiving slots 152. The fingers 65have a shape that corresponds to the shape of the staple receiving slot152. The fingers 65 that are disposed in the staple receiving slot orslots 152 that has the notch 156 have a corresponding extension 67 thatis disposed in the notch 156. As the staple pusher 64 is advanced, thefingers 65 advance, and the finger or fingers 65 that has the extension67 will push the length of suture, strap, or the like 72, from the notch156. The buttress 74 may be as shown in FIG. 3, or it may be anygenerally circular buttress, formed from any of the materials describedabove. The anchor 72 is disposed in the notch 156 to retain the buttress74 on the stapler 10, and can be attached to the buttress 74, or thestapler 10, as discussed above in connection with FIG. 3.

FIGS. 2A and 4 show the tissue contacting surface 51 or 151, and onlyone section of staple receiving slots 52 or 152. In certain embodiments,the buttress fixation system 70 or 170 has twelve staple receiving slots52 or 152 distributed along the tissue contacting surface 51 or 151 andhave the notch 56 or 156. More or fewer such notches 56 or 156 can beprovided to securely attach the buttress 74 to the stapling instrument10.

One of the fingers 65 of the staple pusher 64 is shown in FIG. 5, andincludes the protrusion 67 for pushing the anchor 72 out of the notch156. In any of the embodiments disclosed herein, the stapler 10 includesone or more staple pushers 64 for ejecting the staples 50 from thestaple receiving slots 52, 152 and has a finger 65 that correspond toeach of the slots 52, 152. The fingers 65 that correspond to the slots52, 152 that have the notch 56, 156 for retaining the anchor 72 haveprotrusions 67 for pushing the anchor 72 out of the slot 52, 152.

As shown in FIG. 6, the buttress fixation system 70, 170 may be asdescribed above in connection with FIGS. 1 through 5, with anchors 72for retaining the buttress 274. The buttress 274 itself includes tabs278 at the outer edge 276 of the buttress 274, which can be formed byproviding slits 275 extending from the outer edge of the buttress 274,or by forming tabs 278 that extend outwardly from the outer edge 276.Tabs 278 may also be formed so as to extend from the lower surface ofthe buttress 274, adjacent an inner row or outer row of slots. The tabs278 are arranged to extend into at least some of the staple receivingslots, such as slots 152 or 52 of FIGS. 2 and 4, and an anchor 72extends into the notch associated with at least some of the slots, suchas notches 156 or 56. In this way, the anchor 72 frictionally retainsthe buttress 274 onto the stapler 10, by engaging the tab 278 of thebuttress 274. In any of the embodiments disclosed herein, the buttressfixation system 70, 170 includes a buttress 274 with tabs 278, anchors72, or both, for releasably retaining the buttress 274.

In any of the embodiments disclosed herein, the tissue contactingsurface of the staple cartridge and/or the tissue contacting surface ofthe anvil member, has a stepped or tapered cross-sectional shape.Desirably, one or more rows of staple receiving slots 52 are defined ina surface that has a different height than the surface in which one ormore other rows of staple receiving slots are defined. In addition, inany of the embodiments disclosed herein, the size of the staples incertain of the staple receiving slots may be different than the size ofthe staples in other of the staple receiving slots. For example, theinner row of staples can be smaller in size (such as leg length) thanthe outer row of staples (which has a greater leg length) or, if thereare three rows of staple receiving slots, the inner row of staples cambe smaller than the middle row of staples and the outer row of staples.

In any of the embodiments disclosed herein, the staple receiving slotscan have a curved or angled shape. This allows the staple receivingslots to be positioned more closely to one another in the staplecartridge and/or anvil. The staple forming recesses on the anvil membercan have a corresponding shape so that the recesses can be more closelypositioned with respect to one another on the anvil member. The staplesdesirably have a corresponding shape.

Although circular stapling instruments are described above, the staplinginstrument could have rows of staples, staple forming recesses, andstaple receiving slots that do not define a full circle, but rather asemi-circular, oval, or semi-oval shape. The stapling instrument couldhave rows of staples, staple forming recesses, and staple receivingslots that form some other shape, such as various polygonal shapes, orpartially polygonal shapes. While the present invention has beendescribed in several embodiments, it is not the intention to restrict orin any way limit the scope of the appended claims. Additional advantagesand modifications may readily appear to those skilled in the art.

1.-10. (canceled)
 11. A stapling instrument comprising: a staplecartridge including a tissue contacting surface having a plurality ofstaple receiving slots defined therethrough, each of the plurality ofstaple receiving slots including a staple disposed therein, at least onestaple receiving slot of the plurality of staple receiving slotsincluding a notch defined through the tissue contacting surface andextending radially outwardly from a portion of the at least one staplereceiving slot housing the staple; and a buttress including a bodyportion positioned on the tissue contacting surface of the staplecartridge and at least one anchor attached to the body portion, the atleast one anchor extending into the notch and positioned laterallyadjacent the portion of the at least one staple receiving slot housingthe staple, the at least one anchor releasably retaining the buttress tothe staple cartridge.
 12. The stapling instrument according to claim 11,wherein the plurality of staple receiving slots are arranged in at leasttwo annular rows including an inner row and an outer row, and the atleast one staple receiving slot which includes the notch is in the innerrow.
 13. The stapling instrument according to claim 11, wherein theplurality of staple receiving slots are arranged to include an innerrow, a middle row, and an outer row, and the at least one staplereceiving slot which includes the notch is in the middle row.
 14. Thestapling instrument according to claim 11, wherein the anchor is astrap, a cable, a wire, a thread, or a strand.
 15. The staplinginstrument according to claim 11, wherein the anchor is a suture. 16.The stapling instrument according to claim 11, wherein the anchor iscinched within the notch.
 17. The stapling instrument according to claim11, wherein the notch includes a first portion having a first dimensionand a second portion having a second dimension larger than the firstdimension, the first portion positioned between the second portion andthe staple receiving slot.
 18. The stapling instrument according toclaim 17, wherein the anchor has a cross-sectional dimension smallerthan the first dimension of the first portion of the notch and ispositioned through the first and second portions of the notch such thatthe notch is cinched within the first portion.
 19. The staplinginstrument according to claim 11, wherein the anchor of the buttress isdisposed laterally adjacent to the staple disposed within the at leastone staple receiving slot which includes the notch.
 20. The staplinginstrument according to claim 19, wherein the staple cartridge includesa staple pusher having a plurality of fingers disposed within theplurality of staple receiving slots, at least one finger of theplurality of fingers that is disposed in the at least one staplereceiving slot which includes the notch having an extension extendinglaterally outwardly from the at least one finger and disposed in thenotch.